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OpenTrials
Completed

NCT Number: NCT02165475

Combination Therapy With Biofeedback, Loperamide and Stool Bulking Agents

Background: Biofeedback and medical treatments have been extensively used for moderate fecal incontinence. There is limited data comparing and combining these two treatments.

Aim: To evaluate the effect of biofeedback and medical treatments, separately and in combination.

Methods: Sixty-five consecutive female patients, referred to a tertial center for fecal incontinence were included. The patients were randomized to start with either biofeedback (4-6 months) or medical treatment with loperamide and stool-bulking agents (2 months). Both groups continued with a combination treatments, i.e. medical treatment was added to biofeedback and vice versa. A two-week prospective bowel symptom diary and anorectal physiology were evaluated at baseline, after single- and combination treatments.

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Key information

Conditions

Fecal Incontinence Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Rectal Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Pelvic floor unit, University hospital of Linköping

Linköping, 58185, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients older than 18 years of age
  • Patients with at least one or more episodes of FI during a period of 2 weeks as recorded by bowel function diary
  • Patients from whom written consent was obtained

Exclusion criteria

  • Previous congenital or acquired spinal injury, spinal tumour or spinal surgery
  • Presence of neurological diseases or peripheral vascular disease
  • Uncontrolled diabetes mellitus
  • Congenital anorectal malformations
  • Recent colorectal or gastrointestinal surgery
  • Presence of external full-thickness rectal prolapse
  • Inflammatory bowel disease
  • Chronic diarrhoea
  • Use of tibial nerve or sacral nerve stimulations
  • Ongoing pregnancy
  • Any malignant disease

Treatment and study plan

Biofeedback

Behavioral

Loperamide

Drug

Stool bulking agent (stericulia or isphagula husk)

Drug

Combination of biofeedback and medical treatment

Other

Primary outcomes

  1. symptom diary

    Time frame: Up to eight months

Sponsors and collaborators

Lead sponsor

University Hospital, Linkoeping

Other

Registry information

Official study title

Combination Therapy With Biofeedback, Loperamide and Stool Bulking Agents is Effective for the Treatment of Fecal Incontinence in Women - a Randomized Controlled Trial

Important dates

Study start
2002
Primary completion
2005
First posted
Jun 17, 2014
Registry last updated
Jun 18, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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